Vittoria HCT™ tablets contain three substances called amlodipine,
valsartan and hydrochlorothiazide. All of these substances help to control
high blood pressure.
- Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine stops calcium from moving into the blood vessel
wall, which stops the blood vessels from tightening.
- Valsartan belongs to a group of substances called “angiotensin-II receptor
antagonists”. Angiotensin II is produced by the body and makes the blood
vessels tighten, thus increasing the blood pressure. Valsartan works by
blocking the effect of angiotensin II.
- Hydrochlorothiazide belongs to a group of substances called “thiazide
diuretics”. Hydrochlorothiazide increases urine output, which also lowers
blood pressure.
As a result of all three mechanisms, the blood vessels relax and blood
pressure is lowered.
Vittoria HCT™ is used to treat high blood pressure in adult patients whose
blood pressure is already controlled while taking amlodipine, valsartan and
hydrochlorothiazide and who may benefit from taking one tablet containing
all three substances.

- if you are more than 3 months pregnant. (It is also recommended to avoid
Vittoria HCT™ in early pregnancy - see Pregnancy section.)
- if you are allergic to amlodipine or to any other calcium channel blockers,
valsartan, hydrochlorothiazide, sulphonamide-derived medicines
(medicines used to treat chest or urinary infections), or any of the other
ingredients of this medicine (listed in section 6).
If you think you may be allergic, do not take Vittoria HCT™ and talk to
your doctor.
- if you have liver disease, destruction of the small bile ducts within the
liver (biliary cirrhosis) leading to the build up of bile in the liver
(cholestasis).
- if you have severe kidney problems or if you are having dialysis.
- if you are unable to produce urine (anuria).
- if the level of potassium or sodium in your blood is too low despite
treatment to increase the potassium or sodium levels in your blood.
- if the level of calcium in your blood is too high despite treatment to
reduce the calcium levels in your blood.
- if you have gout (uric acid crystals in the joints).
- if you have severe low blood pressure (hypotension).
- if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic
shock (a condition where your heart is unable to supply enough blood to
the body).
- if you suffer from heart failure after a heart attack.
- if you have diabetes or impaired kidney function and you are treated with
a blood pressure lowering medicine containing aliskiren.
If any of the above applies to you, do not take Vittoria HCT™ and talk
to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vittoria HCT™
- if you have a low level of potassium or magnesium in your blood (with or
without symptoms such as muscle weakness, muscle spasms, abnormal
heart rhythm).
- if you have a low level of sodium in your blood (with or without
symptoms such as tiredness, confusion, muscle twitching, convulsions).
- if you have a high level of calcium in your blood (with or without
symptoms such as nausea, vomiting, constipation, stomach pain, frequent
urination, thirst, muscle weakness and twitching).
- if you have kidney problems, have had a kidney transplant or if you had
been told that you have a narrowing of your kidney arteries.
- if you have liver problems.
- if you have or have had heart failure or coronary artery disease,
particularly.
- if you have experienced a heart attack. Follow your doctor’s instructions
for the starting dose carefully. Your doctor may also check your kidney
function.
- if your doctor has told you that you have a narrowing of the valves in
your heart (called “aortic or mitral stenosis”) or that the thickness of your
heart muscle is abnormally increased (called “obstructive hypertrophic
cardiomyopathy”).
- if you suffer from aldosteronism. This is a disease in which the adrenal
glands make too much of the hormone aldosterone If this applies to you,
the use of Vittoria HCT™ is not recommended.
- if you suffer from a disease called systemic lupus erythematosus (also
called “lupus” or “SLE”).
- if you have diabetes (high level of sugar in your blood). - if you have high
levels of cholesterol or triglycerides in your blood.
- if you experience skin reactions such as rash after sun exposure.
- if you had an allergic reaction to other high blood pressure medicines or
diuretics (a type of medicine also known as “water tablets”), especially if
you suffer from asthma and allergies
- if you have been sick (vomiting or diarrhoea).
- if you have experienced swelling, particularly of the face and throat,
while taking other medicines (including angiotensin converting enzyme
inhibitors). If you get these symptoms, stop taking Vittoria HCT™ and
contact your doctor straight away. You should never take
Vittoria HCT™ again.
- if you experience dizziness and/or fainting during treatment with
Vittoria HCT™, tell your doctor as soon as possible.
- if you experience a decrease in vision or eye pain. These could be
symptoms of an increase of pressure in your eye and can happen within
hours to a week of taking Vittoria HCT™. This can lead to permanent
vision impairment, if not treated.
- if you are taking any of the following medicines used to treat high blood
pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular
if you have diabetes-related kidney problems. - aliskiren.
Your doctor may check your kidney function, blood pressure, and the
amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Vittoria HCT™”.
If any of these apply to you, talk to your doctor.
Children and adolescents
The use of Vittoria HCT™ in children and adolescents under 18 years of
age is not recommended.
Elderly people (age 65 years and older)
Vittoria HCT™ can be used by people aged 65 years and over at the same
dose as for other adults and in the same way as they have already taken the
three substances called amlodipine, valsartan and hydrochlorothiazide.
Elderly patients, particularly those taking the maximum dose should have
their blood pressure checked regularly.
Other medicines and Vittoria HCT™
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Your doctor may need to change your dose
and/or to take other precautions. In some cases you may have to stop using
one of the medicines. This is especially important if you are using any of
the medicines listed below:
Do not take together with:
• lithium (a medicine used to treat some types of depression);
• medicines or substances that increase the amount of potassium in your
blood. These include potassium supplements or salt substitutes containing
potassium, potassium-sparing medicines and heparin;
• ACE inhibitors or aliskiren (see also information under the headings
“Do not take Vittoria HCT™” and “Warnings and precautions”).
Caution should be used with:
• alcohol,sleepingpillsandanaesthetics(medicines allowing patients to
undergo surgery and other procedures);
• amantadine (anti-Parkinson therapy, also used to treat or prevent certain
illnesses caused by viruses);
• anticholinergic agents (medicines used to treat a variety of disorders such
as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness,
muscular spasms, Parkinson's disease and as an aid to anaesthesia);
• anticonvulsant medicines and mood-stabilising medicines used to treat
epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital,
phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol or other resins (substances used mainly to treat
high levels of lipids in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• ciclosporin (a medicine used in transplantation to prevent organ rejection
or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or
cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart
problems);
• verapamil, diltiazem (heart medicines);
• iodine contrast media (agents used for imaging examinations);
• medicines for the treatment of diabetes (oral agents such as metformin or
insulins);
• medicines for the treatment of gout, such as allopurinol; medicines that
may increase blood sugar levels (beta blockers, diazoxide);
• medicines that may induce “torsades de pointes” (irregular heart beat),
such as antiarrhythmics (medicines used to treat heart problems) and some
antipsychotics;
• medicines that may reduce the amount of sodium in your blood, such as
antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce the amount of potassium in your blood, such
as diuretics (water tablets), corticosteroids, laxatives, amphotericin or
penicillin G;
• medicines to increase blood pressure such as adrenaline or noradrenaline;
medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
medicines used for oesophageal ulceration and inflammation
(carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal
anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2
inhibitors (Cox-2 inhibitors);
• muscle relaxants (medicines to relax the muscles which are used during
operations);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin,
clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.
Vittoria HCT™ with food, drink and alcohol
Grapefruit and grapefruit juice should not be consumed by people who are
prescribed Vittoria HCT™. This is because grapefruit and grapefruit juice
can lead to an increase in the blood levels of the active substance
amlodipine, which can cause an unpredictable increase in the blood
pressure lowering effect of Vittoria HCT™. Talk to your doctor before
drinking alcohol. Alcohol may make your blood pressure fall too much
and/or increase the possibility of dizziness or fainting.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Vittoria HCT™ before
you become pregnant or as soon as you know you are pregnant and will
advise you to take another medicine instead of Vittoria HCT™.
Vittoria HCT™ is not recommended in early pregnancy and must not be
taken when more than 3 months pregnant, as it may cause serious harm to
your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Amlodipine has been shown to pass into breast milk in small amounts.
Vittoria HCT™ is not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish to
breast-feed, especially if your baby is a newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make you feel dizzy, drowsy, nauseous or have a
headache. If you experience these symptoms, do not drive or use tools or
machines.

Always take this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure. This will help you get the best results and
lower the risk of side effects.
The usual dose of Vittoria HCT™ is one tablet per day.
- It is best to take the tablet at the same time each day.
Morning is the best time.
- Swallow the tablet whole with a glass of water.
- You can take Vittoria HCT™ with or without food. Do not take
Vittoria HCT™ with grapefruit or grapefruit juice.

Depending on how you respond to the treatment, your doctor may suggest
a higher or lower dose.
Do not exceed the prescribed dose.
If you take more Vittoria HCT™ than you should
If you have accidentally taken too many Vittoria HCT™ tablets, talk to a
doctor immediately.You may require medical attention.
If you forget to take Vittoria HCT™
If you forget to take a dose of this medicine, take it as soon as you
remember and then take the next dose at its usual time. If it is almost time
for your next dose you should simply take the next tablet at the usual time.
Do not take a double dose (two tablets at once) to make up for a forgotten
tablet.
If you stop taking Vittoria HCT™
Stopping your treatment with Vittoria HCT™ may cause your disease to
get worse.
Do not stop taking your medicine unless your doctor tells you to.
Always take this medicine, even if you are feeling well
People who have high blood pressure often do not notice any signs of the
problem. Many feel normal. It is very important that you take this
medicine exactly as your doctor tells you to get the best results and reduce
the risk of side effects. Keep your appointments with the doctor even if
you are feeling well. If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
As for any combination containing three active substances, side effects
associated with each individual component cannot be excluded. The side
effects reported with Vittoria HCT™ or one of its three active substances
(amlodipine, valsartan and hydrochlorothiazide) are listed below and may
occur with the use of Vittoria HCT™.
Some side effects can be serious and need immediate medical
attention. Consult a doctor immediately if you experience any
of the following serious side effects after taking this medicine:
Common (may affect up to 1 in 10 people):
• dizziness, • low blood pressure (feeling of faintness, lightheadedness,
sudden loss of consciousness)
Uncommon (may affect up to 1 in 100 people):
• severelydecreasedurineoutput(decreasedkidney function)
Rare (may affect up to 1 in 1,000 people):
• spontaneousbleeding • irregularheartbeat • liverdisorder
Very rare (may affect up to 1 in 10,000 people):
• sudden wheeziness, chest pain, shortness of breath or difficulty breathing,
• swelling of eyelids, face or lips, • swelling of the tongue and throat which
causes great difficulty breathing , • severe skin reactions including intense
skin rash, hives, reddening of the skin over your whole body, severe
itching, blistering, peeling and swelling of the skin, inflammation of the
mucous membranes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) or other allergic reactions, • heart attack, • inflamed pancreas,
which may cause severe abdominal and back pain accompanied with
feeling of being very unwell, • weakness, bruising, fever and frequent
infections, • stiffness
Other side effects may include:
Very common (may affect more than 1 in 10 people):
• lowlevelofpotassiumintheblood • increaseoflipidsintheblood
Common (may affect up to 1 in 10 people):
• sleepiness, • palpitations (awareness of your heart beat) • flushing
• ankle swelling (oedema), • abdominal pain, • stomach discomfort after
meal, • tiredness, • headache, • frequent urination, • high level of uric acid
in the blood, • low level of magnesium in the blood, • low level of sodium
in the blood, • dizziness, fainting on standing up, • reduced appetite,
• nausea and vomiting, • itchy rash and other types of rash
• inability to achieve or maintain erection
Uncommon (may affect up to 1 in 100 people):
• fastheartbeat, • spinning sensation, • vision disorder, • stomach
discomfort, • chest pain, • increase of urea nitrogen, creatinine and uric
acid in the blood, • high level of calcium, fat or sodium in the blood
• decrease of potassium in the blood, • breath odour, • diarrhoea, • dry
mouth, • weight increase, • loss of appetite, • disturbed sense of taste
• back pain, • joint swelling, • muscle cramps/weakness/pain, • pain in
extremity, • inability to either stand or walk in a normal manner
• weakness, • abnormal coordination, • dizziness on standing up or after
exercising, • lack of energy, • sleep disturbances, • tingling or numbness
• neuropathy, • sudden, temporary loss of consciousness, • low blood
pressure on standing up, • cough, • breathlessness, • throat irritation
• excessive sweating, • itching, • swelling, reddening and pain along a vein,
• skin reddening, • trembling, • mood changes, • anxiety, • depression,
• sleeplessness, • taste abnormalities, • fainting, • loss of pain sensation,
• visual disturbances, • visual impairment, • ringing in the ears,
• sneezing/runny nose caused by inflammation of the lining of the nose
(rhinitis), • altered bowel habits, • indigestion, • hair loss, • itchy skin,
• skin discolouration, • disorder in passing urine
• increased need to urinate at night,
• increasednumberoftimesofpassingurine,
• discomfortorenlargementofthebreastsinmen • pain, • feelingunwell,
• weightdecrease
Rare (may affect up to 1 in 1,000 people):
• lowlevelofbloodplatelets(sometimeswithbleedingor bruising underneath
the skin), • sugar in the urine, • high level of sugar in the blood,
• worsening of the diabetic metabolic state, • abdominal discomfort,
• constipation, • liver disorders which can occur together with yellow skin
and eyes, or dark-coloured urine (haemolytic anaemia), • increased
sensitivity of skin to sun ,• purple skin patches, • kidney disorders,
• confusion
Very rare (may affect up to 1 in 10,000 people):
• decreasednumberofwhitebloodcells, • decrease in blood platelets which
may result in unusual brusing or easy bleeding (red blood cell damage)
• swelling of the gums, • abdominal bloating (gastritis), • inflammation of
the liver (hepatitis), • yellowing of the skin (jaundice), • liver enzyme
increase which may have an effect on some medical tests, • increased
muscle tension, • inflammation of blood vessels often with skin rash,
• sensitivity to light • disorders combining rigidity, tremor and/or
movement disorders, • fever, sore throat or mouth ulcers, more frequent
infections (lack or low level of white blood cells), • pale skin, tiredness,
breathlessness, dark-coloured urine (haemolytic anaemia, abnormal
breakdown of red blood cells either in the blood vessels or elsewhere in the
body), • confusion, tiredness, muscle twitching and spasm, rapid breathing
(hypochloraemic alkalosis), • severe upper stomach ache (inflammation of
the pancreas), • difficulty breathing with fever, coughing, wheezing,
breathlessness (respiratory distress, pulmonary oedema, pneumonitis),
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus),
• inflammation of blood vessels with symptoms such as rash, purplish-red
spots, fever (vasculitis), • severe skin disease that causes rash, red skin,
blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal
necrolysis)
Not known (frequency cannot be estimated from the available data):
• changesin blood tests for kidney function, increase of potassium in your
blood, low level of red blood cells, • abnormal red blood cell test
• low level of a certain type of white blood cell and blood platelet
• increase of creatinine in the blood, • abnormal liver function test
• severely decreased urine output, • inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anaemia)
• decrease in vision or pain in your eyes due to high pressure (possible
signs of acute angle-closure glaucoma), • breathlessness, • severely
decreased urine output (possible signs of renal disorder or renal failure)
• severe skin disease that causes rash, red skin, blistering of the lips, eyes
or mouth, skin peeling, fever (erythema multiforme), • muscle spasm,
• fever (pyrexia), • blistering skin (sign of a condition called dermatitis
bullous)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. By reporting side effects
you can help provide more information on the safety of this medicine.

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and blister after EXP.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
• Do not use any Vittoria HCT™ pack that is damaged or shows signs of
tampering.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.